Atlas of Human Cognition by SEEG (MAPCOG-SEEG)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity Hospital, Grenoble
About this trial
The main objective of MAPCOG\_SEEG is to create a database including brain recordings of cognition performed in clinical routine in patients during the pre-surgical SEEG assessment. This aims to be able to propose the first atlas of human cognition with a high temporal and spatial resolution.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Drug-resistant focal epilepsy
Justified SEEG exploration in the context of presurgical assessment of epilepsy
Written non-opposition to study participation
Intellectual capacities compatible with the compliance in the cognitive tasks
Disqualifiers
Major Patient undergoing a legal protection measure or patient deprived of liberty as a result of a judicial or administrative decision
Impossibility of collecting information on exposure (recent arrival in France, foreign language, etc.)
Pregnant women (Contraindication to SEEG exploration)
Trial population
Adult (Age between 18 and 65 years) patients receiving an SEEG exploration for presurgical evaluation of focal refractory epilepsy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SEEG Group
Procedure/SurgeryVisual and quantitative SEEG signal analysis. As available, collection of behavioral and neuropsychological postsurgical data
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: SEEG Group1 intervention
Trial outcomes
Primary outcomes
1
SEEG recordings using functional brain mapping procedure (composite measures)
Prospective collection of data from SEEG recordings using functional brain mapping procedure performed in clinical routine during the presurgical assessment of patients with drug-resistant epilepsy. These data are represented by the electroencephalographic activity during the realization of the different cognitive tasks proposed to the patients. Electroencephalographic activity will then be analyzed in terms of Dynamic Spectral Imaging and in terms of high frequency activity (\[50-150Hz\]).
Time frame
3 weeksSecondary outcomes
1
Behavioral data (composite measures)
Behavioral data (reaction time and accuracy of response) collected during the presurgical assessment (joint with the SEEG) and during the postsurgical follow-up (approximately 3 months after the surgery) as well as the collection of neuropsychological scores from the presurgical and postsurgical assessment. Behavioral performance and neuropsychological test scores before and after surgery (as available) will allow to evaluate the impact of surgery on cognitive functioning (improvement or deterioration of cognitive performance).
Time frame
3 weeksSponsors and contacts
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Source ClinicalTrials.gov